BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTUNE REVISION BROACH HANDLE

    MDR report key: 7697851 · Received July 18, 2018

    Report

    Report Number
    1818910-2018-64643
    Event Type
    Malfunction
    Date Received
    July 18, 2018
    Date of Event
    June 25, 2018
    Report Date
    June 25, 2018
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    LXH
    UDI-DI
    10603295475910
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT: NULL. DEVICE HISTORY BATCH: NULL. DEVICE HISTORY REVIEW: NULL. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATTUNE REVISION BROACH HANDLES WILL NOT HOLD ON TO THE TIBIAL OR FEMORAL BROACH WHEN BACK-SLAPPING AGAINST THE HANDLE! WE TRIED BOTH HANDLES ON BOTH BONES. BROACH AND HANDLE TIP WERE PRISTINELY CLEAN. WE WERE ABLE TO REPLICATE ON THE BACK TABLE MULTIPLE TIMES. EITHER THE LOCKING ARM ON THE HANDLE IS TOO SHORT OR THE LOCKING MECHANISM WITHIN THE HANDLE IS TOO WEAK. THIS DELAY CAUSED OVER 10 MINUTES OF DELAY IN THE OPERATING ROOM. THE SURGEON IS EXPECTING A WRITTEN RESPONSE AND PHONE CORRESPONDENCE WITH THE KNEE MARKETING OR KNEE ENGINEERING TEAM. THERE WAS ABSOLUTELY DEFICIENCY IN THIS INSTRUMENT TODAY. SURGICAL DELAY: 10 MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539893 ATTUNE REVISION BROACH HANDLE HANDLES LXH DEPUY IRELAND 9616671 AB4187369 10603295475910

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR